Product Code: DMKC0215587
Disease Overview
Ulcerative colitis (UC) is a form of chronic inflammatory bowel disease (IBD), which causes mucosal inflammation affecting the colon. The idiopathic inflammation is commonly associated with the rectum (proctitis) and may extend proximally, evolving into left-sided colitis or extensive colitis (see the figure below). UC typically presents with bloody diarrhea, which may manifest alongside mucus, rectal urgency, tenesmus, and abdominal pain. The disease course is relapsing and remitting with intermittent periods of acute exacerbation, which may be serious enough to warrant therapy escalation, hospitalization, or even colectomy.
Latest key takeaways
As specialty products, therapies for ulcerative colitis (UC) can be expensive, and formulary positioning is paramount to product uptake. Payers are settled in vital contracts that lead them to prioritize broad immunology drugs Humira and Remicade. This has posed a high barrier to newer entrants to the market, which cannot compete in volume and rebates. Biosimilar and generic competition will further undermine the likely premium pricing of newer and pipeline products.
Pivotal upcoming events in the forecast period include the entries of biosimilar adalimumab and generic tofacitinib. Biosimilar adalimumab will enter the US market from 2023, while generic tofacitinib is expected to enter the US market at the end of 2025. Notably, generics have fewer barriers to entry than biosimilars due to numerous factors, including their less complex nature and long-standing familiarity, which facilitates much faster and stronger erosion of branded sales.
Nevertheless, the UC market is projected to expand, propelled by a growing patient caseload and the introduction of pipeline products. Datamonitor Healthcare estimates that in 2018, there were 12.6 million prevalent cases of UC worldwide, and forecasts that number to increase to 13.5 million prevalent cases by 2027.
The UC pipeline holds multiple novel prospects in terms of distinct mechanisms of action and biologics with more convenient formulations. The market will welcome sphingosine 1-phosphate (S1P) receptor modulators etrasimod and Zeposia, interleukin-23 (IL-23) modulator mirikizumab, and toll-like receptor (TLR) 9 modulator Kappaproct. There has been a positive response to Xeljanz as the first novel oral drug competing with biologics for UC, and other companies have recognized this opportunity to provide ease of administration with oral etrasimod, Zeposia, and Rinvoq. Once these products reach the market, they will provide more options for UC patients beyond the established, non-oral anti-TNF class, which is currently the mainstay of treatment. It is likely that these novel products will initially compete at later lines of therapy after the anti-TNF inhibitors, given the latter's enduring stronghold at the first line of biologic therapy.
Although the anti-TNF class are the cornerstone of treatment, ~10-30% of patients are non-responders to initial treatment and ~23-46% of patients lose response over time. Additionally, the class has black box warnings for the risk of serious infections and malignancy. These drugs are favored due to long-standing physician familiarity and prioritization in formularies; however, they do not satisfy persisting unmet needs in the UC market.
Critical unmet needs and opportunities include demonstrating strong efficacy to treat inadequate responders, clinically balanced drugs that offer both efficacy and safety, producing superior data over anti-TNF inhibitors and available drugs in the same class through head-to-head trials, and competitive pricing, which is essential to facilitate better positioning in the treatment algorithm.
TABLE OF CONTENTS
CONTENTS
OVERVIEW
DISEASE BACKGROUND
- Definition
- Patient segmentation
TREATMENT
- ACG treatment guidelines
- ECCO treatment guidelines
- NICE treatment guidelines
EPIDEMIOLOGY
MARKETED DRUGS
PIPELINE DRUGS
KEY REGULATORY EVENTS
- Tentative Xeljanz XR Approval Among Several For Zydus Cadila
- Extra Indications Approved For Celltrion's Remsima SC
- FDA Approves Mylan's Humira Biosimilar
- Zeria UC Drug Finally To Market
- EU Approves Takeda's Injectable Entyvio for IBD
- Ulcerative Colitis Patients In England Get New Treatment Option
- HTA: Scotland Says Yes To Stelara For Ulcerative Colitis
- EU: Pfizer Warns Doctors About Blood Clot Risk With Xeljanz
- CHMP Positive On Pfizer's Adalimumab
- EMA Recommends Caution For Pfizer's Xeljanz
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Scipher Hopes IBD Alliance With Galapagos Is The First Of Many
- AZ Gets IBD Drug Back From Allergan
- With Celgene Acquisition Closed, Bristol Faces Major Milestones
- Pacts In Medtech: BI, Inflammasome Work On Retinal Disease; Takeda And Prometheus Take On IBD
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
DRUG ASSESSMENT MODEL
- Biologic DMARDs
- Non-biologic DMARDs
- DNA-based immunomodulatory sequence
MARKET DYNAMICS
FUTURE TRENDS
- Novel pipeline products are poised to diversify the UC market
- Brands will face headwinds as the UC market is penetrated by biosimilars and generics
CONSENSUS FORECASTS
RECENT EVENTS AND ANALYST OPINION
- Jyseleca for Ulcerative Colitis (October 12, 2020)
- Etrolizumab for Ulcerative Colitis (October 11, 2020)
- Zeposia for Ulcerative Colitis (October 10, 2020)
- Etrolizumab for Ulcerative Colitis (August 9, 2020)
- Etrolizumab for Ulcerative Colitis (August 9, 2020)
- Zeposia for Ulcerative Colitis (June 2, 2020)
- Jyseleca for Ulcerative Colitis (May 20, 2020)
- Neihulizumab for Ulcerative Colitis (May 4, 2020)
- Inflectra for Ulcerative Colitis (September 19, 2019)
- IMU-838 for Ulcerative Colitis (September 5, 2019)
- Kappaproct for Ulcerative Colitis (August 27, 2019)
- Camligo for Ulcerative Colitis (July 31, 2019)
- Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
- Multiple Drugs for Ulcerative Colitis (June 25, 2019)
KEY UPCOMING EVENTS
UNMET NEEDS
- Treatments that improve the natural history of UC
- Effective, well-tolerated treatments that induce rapid and sustained remission
- There is critical unmet need for predictive biomarkers
- Novel oral treatments
BIBLIOGRAPHY
APPENDIX
LIST OF FIGURES
- Figure 1: Ulcerative colitis disease extent
- Figure 2: Trends in prevalent cases of ulcerative colitis, 2018-27
- Figure 3: Overview of pipeline drugs for ulcerative colitis in the US
- Figure 4: Pipeline drugs for ulcerative colitis, by company
- Figure 5: Pipeline drugs for ulcerative colitis, by drug type
- Figure 6: Pipeline drugs for ulcerative colitis, by classification
- Figure 7: Probability of success in the ulcerative colitis pipeline
- Figure 8: Clinical trials in ulcerative colitis
- Figure 9: Top 10 drugs for clinical trials in ulcerative colitis
- Figure 10: Top 10 companies for clinical trials in ulcerative colitis
- Figure 11: Trial locations in ulcerative colitis
- Figure 12: Ulcerative colitis trials status
- Figure 13: Ulcerative colitis trials sponsors, by phase
- Figure 14: Datamonitor Healthcare's drug assessment summary for ulcerative colitis
- Figure 15: Market dynamics in ulcerative colitis
- Figure 16: Future trends in ulcerative colitis
- Figure 17: Jyseleca for Ulcerative Colitis (October 12, 2020): Phase IIb/III - SELECTION
- Figure 18: Etrolizumab for Ulcerative Colitis (October 11, 2020): Phase III - GARDENIA (vs. Infliximab; Sustained remission study)
- Figure 19: Etrolizumab for Ulcerative Colitis (August 9, 2020): Phase III - HIBISCUS I (vs. Adalimumab; TNF Naive; Induction), Phase III - HIBISCUS II (vs. Adalimumab; TNF Naive; Induction), Phase III - LAUREL (TNF Naive/Refractory; Maintenance)
- Figure 20: Etrolizumab for Ulcerative Colitis (August 9, 2020): Phase III - HICKORY (TNF Intolerant)
- Figure 21: Zeposia for Ulcerative Colitis (June 2, 2020): Phase III - TRUE NORTH
- Figure 22: Jyseleca for Ulcerative Colitis (May 20, 2020): Phase IIb/III - SELECTION
- Figure 23: Neihulizumab for Ulcerative Colitis (May 4, 2020): Phase II - Proof of Principle
- Figure 24: Kappaproct for Ulcerative Colitis (August 27, 2019): Phase IIb - CONDUCT
- Figure 25: Camligo for Ulcerative Colitis (July 31, 2019): Phase III - Pouchitis
- Figure 26: Key upcoming events in ulcerative colitis
LIST OF TABLES
- Table 1: American College of Gastroenterology ulcerative colitis activity index
- Table 2: 2019 ACG recommendations for induction of remission in patients with mildly active UC
- Table 3: 2019 ACG recommendations for maintenance of remission in patients with previously mildly active UC
- Table 4: 2019 ACG recommendations for induction of remission in patients with moderately to severely active UC
- Table 5: 2019 ACG recommendations for maintenance of remission in patients with previously moderately to severely active UC
- Table 6: 2019 ACG recommendations for hospitalized patients with acute severe UC
- Table 7: 2017 ECCO treatment guidelines for proctitis
- Table 8: 2017 ECCO treatment guidelines for left-sided UC
- Table 9: 2017 ECCO treatment guidelines for extensive UC
- Table 10: 2017 ECCO treatment guidelines for severe UC
- Table 11: 2017 ECCO treatment guidelines for maintenance of remission
- Table 12: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctitis
- Table 13: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctosigmoiditis and left-sided UC
- Table 14: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate extensive UC
- Table 15: 2019 NICE treatment guidelines regarding biologics and JAK inhibitors for moderate-severely active UC for all extents of disease
- Table 16: 2019 NICE treatment guidelines for acute severe UC for all extents of disease
- Table 17: 2019 NICE treatment guidelines for maintaining remission
- Table 18: Prevalent cases of ulcerative colitis, 2018-27
- Table 19: Marketed drugs for ulcerative colitis
- Table 20: Pipeline drugs for ulcerative colitis in the US
- Table 21: Historical global sales, by drug ($m), 2015-19
- Table 22: Forecasted global sales, by drug ($m), 2020-24
- Table 23: Jyseleca for Ulcerative Colitis (October 12, 2020)
- Table 24: Etrolizumab for Ulcerative Colitis (October 11, 2020)
- Table 25: Zeposia for Ulcerative Colitis (October 10, 2020)
- Table 26: Etrolizumab for Ulcerative Colitis (August 9, 2020)
- Table 27: Etrolizumab for Ulcerative Colitis (August 9, 2020)
- Table 28: Zeposia for Ulcerative Colitis (June 2, 2020)
- Table 29: Jyseleca for Ulcerative Colitis (May 20, 2020)
- Table 30: Neihulizumab for Ulcerative Colitis (May 4, 2020)
- Table 31: Inflectra for Ulcerative Colitis (September 19, 2019)
- Table 32: IMU-838 for Ulcerative Colitis (September 5, 2019)
- Table 33: Kappaproct for Ulcerative Colitis (August 27, 2019)
- Table 34: Camligo for Ulcerative Colitis (July 31, 2019)
- Table 35: Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
- Table 36: Multiple Drugs for Ulcerative Colitis (June 25, 2019)
